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Ruxolitinib + Temozolomide + Radiation for Glioblastoma

Phase 1

Waitlist Available

Led By David Peereboom, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Arm 2: Patients must have supratentorial methylated MGMT high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma)

Arm 1: Patients must have unmethylated MGMT supratentorial high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma)

Must not have

Heart diseases including abnormal electrocardiogram (EKG)

Patients who have previously received other treatments for their cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks after beginning treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well Ruxolitinib works with temozolomide and radiation to treat patients with gliomas or glioblastomas.

Who is the study for?

This trial is for adults with certain high-grade brain tumors (gliomas or glioblastoma) that haven't spread beyond a specific area and have not been treated before. Participants need to be fairly independent, able to consent, and willing to use birth control. They can't join if they have other serious illnesses, HIV, hepatitis B/C, heart issues, are pregnant or on blood thinners.

What is being tested?

The study tests Ruxolitinib's effectiveness when combined with standard brain cancer treatments: radiation and Temozolomide. Ruxolitinib targets cell proteins to stop tumor growth but isn't FDA-approved yet for these cancers. Temozolomide damages tumor DNA.

What are the potential side effects?

Ruxolitinib may cause infections due to immune system effects, bleeding problems from low platelets, anemia from low red blood cells count; liver function changes; cholesterol level changes; headaches; dizziness and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of brain tumor with a certain genetic feature.

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My brain tumor is a high-grade type and tests show it is unmethylated.

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I can take care of myself with a little help from others.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart issues or an abnormal EKG result.

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I have had treatments for my cancer before.

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I have taken ruxolitinib before or am allergic to the study drug.

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I've had a second brain surgery for my tumor after radiation and temozolomide treatment.

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I am currently taking blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks after beginning treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks after beginning treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks after beginning treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of patient study specific adverse events as a measure of safety

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04530344

13%

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 1.5% Cream BID

Vehicle Cream BID

Total

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ruxolitinib + radiation x 60 Gy for 6 weeksExperimental Treatment2 Interventions

Unmethylated O6-methylguanine DNA methyltransferase (MGMT) Glioblastoma and grade III glioma Every patient gets ruxolitinib + radiation x 60 Gy for 6 weeks over 6 weeks. The dose of radiation therapy is fixed at 60 Gy over 6 weeks

Group II: ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/mExperimental Treatment3 Interventions

Methylated MGMT Glioblastoma and grade III glioma. Arm 2 will start once the safe dose has been established for Arm 1 for every dose level. Every patient gets ruxolitinib + radiation x 60 Gy + daily temozolomide at 75 mg/m2 for 6 weeks over 6 weeks. The dose of radiation therapy is fixed at 60 Gy over 6 weeks (2 Gy x 30). The dose of temozolomide is 75 mg/m2 daily for 6 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ruxolitinib

2017

Completed Phase 3

~660

radiation

2014

Completed Phase 3

~1440